United Stttv Environmental Protection Aomcy Offloi of PwlddM and Toxic Offlo* of Pwicfd* Program! (TS-766C) WMiington. DC 2O460 vvEPA Pesticide Fact Sheet Name of Chemical: Reason for Issuance: Date Issued: Fact Sheet Number: CAPTAN, N-trichloromethvlthio-A- cyclohexene-1,2-dicarboximide Issuance of Registration Standard March 6, 1986 ' 75 Description of Chemical Generic Name: N-trichloromethylthio-4-cyclohexene-l, 2-dicarboximide Common Name: Captan Trade Names: Merpan, Orthocide, SR-406, and Vaneide 89 EPA Shaughnessy Code: 081301 Chemical Abstract Service (CAS) Number: 133-06-2 Year of Initial Registration: 1951 Pesticide Type: Fungicide U.S. Producer: Chevron Chemical Company Stauffer Chemical Company Makteshim Beer Sheva Chemical Works, Ltd. Calhio Chemicals, Inc. Use Patterns and Formulations Application Sites: Captan (N-trichlorcmethylthio-4-cyclohexene-l ,2- dicarboximide) is a fungicide federally registered for use on almonds, apples, apricots, asparagus, avocados, beans, beets, blackberries, blueberries, broccoli, Brussels sprouts, cabbage, cantaloupes, carrots, cauliflower, celery, cherries, corn (sweet), cotton, cranberries, cucumbers, dewberries, eggplants, grapefruits, grapes, honeydew melons, kale, lemons, lettuce, limes, mangoes, mustard, nectarines, onions, oranges, peaches, pears, peas, peppers, pineapples, plums, potatoes, pumpkins, quinces, raspberries, rhubarb, rutabagas, soybeans, spinach, squach, strawberries, tangelos, tangerines, taro, tomatoes, turnips, and watermelons. The following crops may be seed-treated: Alfalfa, asparagus, barley, beans, beans (lima), beets (table), bluegrass, broccoli, Brussels sprouts, cabbage, cantaloupes, carrots, cauliflower, clover, collards, conifers (Douglas fir, Red pine, Scotch pine, Norway spruce), corn (field and sweet), cotton, cowpeas, crucifers, cucumbers, eggplants, flax, forage grasses, kale, lentils, lespedeza, millet, milo, muskmelons, mustard, oats, okra, onions, peanuts, peas, peppers, pineapples, pumpkins, radishes, rape, rice, rutabagas, rye, safflower, sesame, small-seeded legumes, ------- 2 sorghum, soybeans, spinach, squash, sugar beets, sunflc iers, Swiss chard, tanatoes, trefoil, turnips, watermelons, and wheat. Ornamental crc uses include: foliar applications to azaleas, begonias (tubercxis), camel li as, carnations, chrysanthemiins, d ichondra, grasses (ornamental in nonpastered areas only), grasses (lawn seedbeds), hollyhocks, lilacs, snapdragons, spireas, roses, and stocks; for soil in plant beds and on green house benches used for the culture of flowers, roses shrubs and trees; and as a dip application to gladiolus corms, to begonia tubers, and to azalea cuttings. Captan may be applied to packing boxes for use in storage and shipping of fruits and vegetables and to soil used in greenhouses for culture of ornamentals and vegetables. Household Uses Include: application to fruit, vegetable and ornamental gardens, house plants and lawns, in paints (oil based), on surfaces (awnings, blankets, boats, closets, clothing, draperies, floors, leather goods, luggage, mattresses, rugs, shoes, storage rooms, upholstery, walls, workshops, and on other articles. Industrial uses include incorporation into lacx uers, paints (oil based), paper, paste (wallpaper flour), plasticizers, polyethylene, rubber stabilizer, textiles, vinyl, and vinyl resins. Types of Foritu lat ions: I)ists, wettable powders, ajueous suspensions, and granules. Types and Methods of Application: I).lsting, spraying, misting, dipping, mixing, and low pressure bomb aerosols. Application Rates: See use patterns in Compilations of Registered Uses of Fungicides and Nematicides, Part I, Pages C1OOO-O1 to C10O0 .21. Usual Carriers: Clay, talc, silica, and water. 3. Scientific Findings Chemical Characteristics: Physical State: Pure is white crystals, technical is white to boff colored arrorphous powder. Color: White to boff Odor: Pure is odorless, the technical is pungent. Melting Point: 158164 °C Vapor Pressure: Less than 10 m Hg at 25 °C. Solubility: Practically insoluble in water, soluble in acetone, ethanol, kerosene, ,cylene, chloroform, and benzene. Stability: Regarded as stable. Decomposes slowly at the melting point. In solution captan decomposes rapidly depending on the pH and te perature, being slower at pH 4 and rapid at pH above 10. ------- 3 Toxicity Characteristics : Acute Oral LD 50 - Rat - 9 gm/kg, Category iv Acute Inhalation LD50 - Rat males 5.8 mg/L, Category III females ) 8.9 riujL, Category III Eye Irritation Rabbit corneal opacity, iris and conjunctive irritation present through day 21, Category I. Dermal Sensitization Moderate sensitizer. Subchronic Rodent Filled by the 2 year chronic feeding study in rats. Teratogenicity Rabbit not teratogenic at 6, 12, 25, or 60 mg/kg/day. Maternal toxicity observed as weight loss at high dosage. Hamster dosed at 50, 200, and 400 mg/kg/day. Severe maternal weight loss at 400 mg/kg/day. Incidence of skeletal abnormalities; i. e., fused ribs, was increased at high dosage. These lesions were considered to be within normal background incidence. Reproduction and Fertility Effects (feeding) a. Three Generation Reproduction Study Rats: Rats were fed 25, 100, 250, and 500 mg/kg/day for three generations. Body weight reductions occurred at 100, 250, and 500 mg/kgJday and a reduction of food consumption occurred at 100, 250, and 500 mg/kg in F 1 males and F 2 females. Pup litter weights were decreased in all dosage groups. b. One Generation Reproduction Study Rats: Rats were fed a diet of 6, 12.5, and 25 mg/kg/day. treatnent related effects due to captan were seen. (The t.OEL for these studies (a and b) when ca bined, is 12.5 mg/kg/day.) Mutagenicity i. Gene Mutation o In vivo smatic mutation assay with mice no mutations were Eserved. o Captan was mutagenic to various strains of S.. typhimurium in saline. Decreased mutagenicity was observed when captan was incubated with blood or urine. Captan was not mutagenic in the host rr diated assay in mice or rats with S. typhimurium hisG46 or T l950. Negative findings were also obtained in vitro with blood or urine of captan-treated mice or rats. o Captan was rm.itagenic for point mutations in E. coli and ------- -4- S. typhiniirium . H iever, it did not produce heritable chroncson aberratior in vivo (this was the oDnclus ion of a working group chaired by W. M. Generoso.) o Captan was not mutagenic for the dcninant lethal test using C3H male and SLR-ICR female mice. significant increases in chrcxiosanal aberrations were observed in human fibroblasts in vitro or in bone marr i cells of Wistar rats in vivo . ii. Chra sana1 Aberrations o Chinese hamster 179 cells were treated with captan technical at concentrations up to 6.0 x 10 M. Chrt sanal aberrations were observed at 4.5 x i0 5 . Increased frequency of sister chrcrnatid exchanges were observed at 1 .5 x i0 M and above. iii. Unscheduled D Synthesis (UDS) o W138 cells were incubated with captan technical and tritiated thyrnidine for 3 hr without or 1 hr with S9 activation. The D was extracted and the incorporated labeled thymidine counted. Captan did not induce UDS in W138 cells. Chronic Toxicity (feeding) a. Rat In a rat feeding study at 0, 25, 100 and 250 rrc /Kg/day treatmant related neoplasms (renal tutxilar adenanas and carcinanas) in males were observed at 100 and 250 r /Kg/day. The LEL was 100 nk /kg/day based on hepatocellular hypertrophy, increased kidney weight (male and female) and decreased body weight (male and female). The I DEL was 25 no/Kg/day. This study partially satisfies the chronic testing requiremant for registration. Oncogenicity (feeding) a. Rat See a above, chronic toxicity in the rat. b. Mouse ( high dose study ) In a CD- ]. nouse study technical captan at dietary concentrations of 6 ,000, 10 ,000, and 16 ,000 p xn induced both benign and malignant duodenal turrors in both males and females. C. Mouse ( l i dose study ) In a second CD-i n xise study there was an increased incidence of focal hyperplasia, adenana/polyp(s) and primary carcincinas in the gastrointestinal track of both male and female mice at the highest level tested (6,000 p n) and a possible increase at the lc ier dosage levels. ------- -5- Physiological and Biochemical Behavioral Characteristics : Foliar Absorption: Captan and/or its tretabolites and degradates is (are) absorbed by roots and shoot of plants. Trarsiocation: Captan and/or its metabolites and degradates is (are) translocated in plant tissue. Captan and/or its rrietabolites and degradates is (are) absorbed and translocated within plants as a result of seed treatment, soil treatment and foliar application. Mechanism of Pesticidal Action: Unknc in Metabolism and Persistence in Plants and Animals: The metabolism and accunulation of captan in plants are not understood. The metabolism of captan is understood for ruminants but not for avian species. Environmental Characteristics : Data gap Ecological Characteristics : Hazards to Fish and Wildlife Bluegill sunfish 96 hr LC = 0.047 0.111 ppe Rainb i trc*.it 96 hr LC = 0 .066 0 .080 p xn Characterized as very highly toxic to both cold water and warm water fish. Daphnia magna : 48 hr LC = 7.06 9.96 p n oderately toxic to aquatic invertebrates. Avian 1\Dxicity: LC = quail > 2400 p n Avian Reproduction: Available data indicate that captan does not impair avian reproduction. Potential problems related to endangered species. The P ency has made a preliminary finding that the use of captan as a fungicide in rice, cranberries, and citrus may affect the status of endangered birds, fish, and insect species. An endangered bat may be affected by the use of captan on taro in Hawaii. The Agency will seek the opinion of the U.S. FLsh and Wildlife Service in these matters, to better determine what, if any, actions are necessary to protect these species. Efficacy Review Results: Captan product registrations with EPA have been supported with efficacy data. 1 lerant strains of target plant pathogens have not been reported. ------- 6 Tolerance Assessents: 1. List of Crcps and Tolerances: The foll ing table lists the present status for tolerances in parts per million (pgrn) for residues of captan: Part Per Million in Captan Residues Raw Agricultural Cc modity U.S. Canada Mexico Codex ALMOND, HULLS 100 .01* ALMONtS 2.01 APPLES 25.0** 5.0 25.0 25.0 APRICOTS 50.0 5.0 20.0 AVOCAIX 25.0 - - - BEArS, DRY 25.01 25.0 BEMS, SUCCULENT 25.01 25.0 10.0 BEETS, GREE?S 100 .0 BEEIS, i ors 2.0 BLACKBERRIES 25.0 - BLUEBERRIES (HUCKLEBERRIES) 25.0 5.0 20.0 BROCCOLI 2.0 2.0 BRUSSELS SPI fIS 2.0 - CABBP E 2.0 2.0 CAN ALO(JPS 25.0 25.0 CAR1 JTS 2.0 2.0 CATILE, FAT 0.05 CATTLE, MBYP 0 .05 CATTLE, MEAT 0.05 CP 1JLIFLCWJER 2.0 2.0 CELERY 50.0 50.0 CHERRIES 100 .0 5.0 50 .0 COLLAREE 2.0 CORN, SWEET (K+CWHR) 2.0 2.0 OT ON, SEED 2.0 2.0 CRABAPPLES 25.0 5.0 25.0 25.0 CRABERRIES 25.0 5.0 10.0 CtJCUMBE 25.0 25 .0 10 .0 DEWBERRIES 25.0 - - EXGPLANr 25.0 GARLIC 25.0 25.0 GRAPEFRUIT 25.01 15.0 GRAPES 50.0 5.0 *1 Interim tolerance pending evaluation (under Special Review) of trar fer of captan residues to neat, milk, and eggs frcxn feeding the raw agricultural ccxrvdity or their byproducts. ** Established tolerance under regulation, Section 180 .103, 40 CER. ------- 7 Continued. Part r Million in Captan Residues Raw Agricultural Camod ity U.S. Canada - Mexico Codex HOGS, FAT 0.05 HOGS, MBYP 0.05 HCX3S, MEAT 0.05 - HONEYDEW MELO( 6 25 .0 25 .0 KALE 2.0 - - LEEKS 50.0 LEtOt S 25.01 15.0 LET11J 100 .0 100 .0 10 .0 LIMES 25.01 15.0 MA OES 50.0 50.0 MUSKMELOtS 25.0 25.0 MUSTARD, GREEtS 2.0 - - - NEC AR1NES 50 .0 - ONIOtE, DRY BULB 25.0 - 25.0 ONIOt E, GREEN 50.0 - 50.0 - ORAI I3ES 25.01 15.0 PEACHES 50.0 5.0 40.0 15.0 25.0 5.0 25.0 25.0 PEAS, DRY 2.0 - 2.0 PEAS, SUCCULENT 2 .0 - 2.0 - PEPPE 25.0 - 10.0 PIMEt1 103 25.0 10.0 PINEAPPLES 25.01 25.0 PLU? S (FRESH PRUNES) 100 5.0 10 .0 TKIOES 25.01 2 .0 1 5.0 PUMPKItS 25.0 - - QUINJES 25.0 - - RASPBERRIES 25.0 5.0 10.0 RHUBARB 25.0 - 15.0 R1JTAB.A AS, ROOTS 2 .0 - SHALLO1S 50 .0 - SOYBEArS, DRY 2 .0 2 .0 SOYBEAtE, SUCCULENT 2.0 2.0 - SPI Gi 100.0 100.0 20.0 )UASH, SUMMER 25.0 - - - SQUASH, WINTER 25.0 - - - STRAWBERRIES 25.0 5.0 25.0 20 .0 TAt 3ERI NES 25.01 15.0 TA D (OORN) 0.25 - TOMATOES 25.0 5.0 15.0 I1JRNIPS, GREEtS 2.0 - - IIJRNIPS, O1S 2.0 - WATERMELOtE 25.0 25.0 ------- 8 A feed aiditive regulation ( 561.65, Title 21, Code of Federal Regulations; Parts 500 to 599) permits residues of captan at 100 .0 p xn remaining on corn seed fran its intended use as a seed protectant after detreatuent. Detreated corn seed can be used only as a feed for cattle and hogs up to 14 days prior to slaughter. A food aiditive regulation (S193 40, Title 21, Code of Federal Regulations Parts 170 to 199) permits 50.0 ppn residues of captan in or on washed raisins when present as a result of fungicidal treatment by preharvest application to grapes and postharvest application during the drying process. tb tolerances have been established for captan residues in or on any crc c iodity for which captan is registered solely for seed or plant propagule application, because heretofore seed or plant propagule applications were considered as nonfood uses. Seed use sites are listed under Use Patterns and Forntilations. Data Gaps in Residue Chemistry o Available plant metabolism data are not catpletely adequate for identifying the rnetabolites that may result fran the maximum uses and necessary to support the established tolerances. o Available animal metabolism data are not adequate to support the tolerances in meat; and to establish tolerances in milk, and poultry and eggs. o For enforcement purposes, FtY S Pesticide Analytical Marnial, Method I, Vol. II, Pesticide Regulation Section 180.103 is acceptable for plant caninirxlities. o validated method is available for enforcement of tolerances for residues of captan in animal catutodities. o Inadequate data are available on the storage stability of residues of captan in animal camodities or in or on plant caTnodities. o The follc ing uses need tolerances to all i continued registrations: California, Special Local Needs registration CA780027 Use of captan as a seed treatment or as a root dip in the culture of asparagus. Washington, Special Local Needs registration WA800035 Use of captan as a seed treatment or as a soil treatment in the culture of kohirabi. Usepatterns for treatment of soil and greenhouse benches in which vegetables (without tolerances) are gr n. o The data are insufficient to assess the established tolerance for residues in or on detreated seed corn because no data were sutrnitted depicting residues resulting fran detreated seed that originally had been treated at the rnaxin jin alla iab1e rate A mechanism must be implemented to prevent the feeding of detreated seed corn which contains residues of pesticides in addition to those of Captan. ------- 9 o HeretofOre, seed treatments and plant propagule treatments have been coneidered nonfood uses. Available plant metabolism data indicate that residues of captan may be taken up into mature plants fr n treated seed. therefore, seed treatments are uses for which residue data and requests for EPA Pesticide Petitions for proposed tolerances must be submitted. o Processing studies are required for the foll ing cai odities: potatoes, beans, soybeans, tanatoes, oranges, plums, sweet corn, and cottonseed. o Captan may be used as a ccxnponent of paper and paper board that may cc ne in contact with aqueous and fatty foods (21 CFR 176.170(c)]. Residue data to support this regulation are required to support the EPA registered use-pattern. Alternatively, label amendments are required to restrict the use of captan-treated packing boxes for fruits and vegetables having tolerances for residues of captan. o The theoretical maximum residue contribution (l C) fran established tolerances is 12 nv/day based a 1.5 kg diet. The changes in the residue definition, the requested tolerance proposals, and the pending tolerances noted above will all affect a change in the TMRC level. The data requirements to support established tolerances as listed in 40 CFR 180 .103 are identified. o The Provisional Maximum Permissible Intake (PMPI) for a 60 kg person is 0.75 ma/day based on a Provisional Acceptable Daily Intake (P DI) of 0.0125 mg/kg. The present IMRC represents 1600 percent of the PMPI. The inclusion of the major netabolite (ThPI) in the tolerance expression may result in an increase in the 1IIRC and a greater percentage of the PMPI utilized. o The PADI for captan is based on a reproductive toxicity study in rats. A no-observec effect level ( DEL) was established at 12.5 rr /k /day for decreased pup weights. A safety factor of 1000 is used to derive the PADI because there was only chronic data on one species. The PADI will be changed to an ADI when chronic data on a second species (nonrodent) are submitted and found adequate. The data fran the mst sensitive species and a safety factor of 100 will be used. The )EL of 12.5 rrv/kg/day was based on reproductive toxicity excluding the issue of onoogenicity for which a risk assessment has been made. 4. Suini ary of Regulatory Positions and Rationale The Agency has concluded that studies conducted with mice and rats have sh in statistically significant increases in incidences of certain tujrors. Use of captan results in dietary and envirorinental exposure that may pose unreasonable risks to human health unless certain steps are taken. Accordingly, the Agency proposed in the Federal Register of June 21, 1985 ( ) FR 25884) to cancel or deny federal registrations of products containing captan for use on food crops with the proviso that in the final decision EPA would continue any use on food where data submitted denonstrate that captan residues on food ------- 10 are sufficiently 1c ier than EPAS estimates or that alternative application n thods will sufficiently reduce dietary exposure to captan. EPA also proposed in its preliminary determination that protective clothing and/or equiprr nt be worn or used for specific nonfood agricultural and nonagricultural uses of captan and that revised labeling be required on products intended for non-food uses. Extensive dietary data are due frcxn registrants in May, 1987. A decision docun nt, Position E cun nt inber 4, is expected to be issued in August, 1988. Required labeling reflects use restrictions needed to reduce human exposure to captan. The foll iiing areas of labeling will be required within 90 days fran the receipt of the Standard: 1. Ingredient Staten nts 2. Precautionary Staten nts 3. Envirortn nta1 Hazards Staten nts 4. Use Precaution Statenents Suninary of Risk/Benefit Review An EPA docunent entitled Intent to Cancel Registration of Pesticide Products Containing Captan; Availability of Position Docurtent 2/3 (50 FR 2588425899, June 21, 1985) discusses the risks and benefits of cap tan. 5. Sumary of Major Data Gaps Product Chemistry Tox ico logy Acute Testing Subchronic Testing Chronic Testing Special Testing Environnental Fate Phutodegrat ion Metabolism Studies Laboratory Mobility Studies Dissipation Studies Field Accunulation Studies Subdivision K, Reentry Studies Wildlife and Aquatic Organisns Aquatic Organism Testing bntarget Insect Testing Aquatic Insects Residue Chemistry 6. Contact person at EPA Eugene M. Wilson Assistant Product Manager (21) Fungicide/Herbicide Branch Registration Division (TS767C) Office of Pesticide Programs Washington, D. C. 20460 ------- |